RESTORIS 180513Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486000622), received between Sep 1, 2020 and May 20, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K082172, K090763, K150307, K220930, K242831); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2021Unstable; Unstable

  PKA WAS REVISED TO TKA DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11856028 ↗
• InjurySep 1, 2020Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REVISED A MAKO MCK MEDIAL PKR DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. HE THINKS IT WAS DUE TO CEMENT TECHNIQUE AT TIME OF IMPLANTATION. THE CONSTRUCT IS TWO YEARS OLD. THERE IS VISIBLE WEAR ON THE POLY INSERT. HE BELIEVES IT IS TOO YOUNG TO HAVE EXPERIENCED POLY WEAR, AND WOULD LIKE THE INSERT TO BE EXAMINED, ASSESSED AND REPORTED BACK TO HIM PLEASE.

  Patient problems: Injury

  MAUDE report 10477460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082172, K090763, K150307, K220930, K242831. One submission often covers many models, so check the product and lot details in each record.

• Z-1385-2023 · Mar 10, 2023 · Open, Classified
  stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
• Z-1386-2023 · Mar 10, 2023 · Open, Classified
  stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
• Z-2051-2018 · Jan 19, 2018 · Terminated
  Restoris MCK Onlay Insert Extractor.
• Z-1031-2016 · Jan 15, 2016 · Terminated
  Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
• Z-1132-2014 · Jan 9, 2014 · Terminated
  Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartme